FDA-Device2012-10-17Class II
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Beckman Coulter Inc.
Hazard
The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping
Sold states
Worldwide Distribution - USA (nationwide) and the following countries: Albania Australia Austria Bahrain Bangladesh Barbados Belarus Belgium Bosnia and Herzegovina Bulgaria Burundi Canada Chile China Colombia Croatia Czech Republic Denmark Ecuador El Salvador Finland France French Guiana French Polynesia Germany Greece Guadeloupe Hong Kong India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea, Republic of Kuwait Libyan Arab Jamahiriya Lithuania Macao Malaysia Mexico Monaco Morocco Namibia Netherlands New Zealand Nigeria Norway Oman Pakistan Panama Poland Puerto Rico Qatar Reunion Romania Russian Federation Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sudan Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Uruguay
Affected count
137,445 units total (26,155 units in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0033-2013Don't want to check this manually?
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